Irinoll Special Precautions



Venus Remedies


Cosma Medical
Full Prescribing Info
Special Precautions
Care of Intravenous Site: Irinotecan is administered by intravenous infusion so care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation. Should extravasation occur, flushing the site with sterile water and application of ice are recommended.
Pre-medication with Antiemetics: Irinotecan is emetogenic. It is recommended that patients receive pre-medication with antiemetic agents starting at least 30 minutes before administration of irinotecan.
Treatment of Cholinergic Symptoms: Prophylactic and therapeutic administration of 0.25 to 1 mg of intravenous or subcutaneous atropine should be considered (unless clinically contraindicated) in patients experiencing rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, abdominal cramping, or diarrhea (occurring during or shortly after infusion of irinotecan). These symptoms are expected to occur more frequently with higher irinotecan doses.
Patients at Particular Risk: Physicians should exercise particular caution in monitoring the effects of irinotecan in the elderly (>65 years) and in patients who had previously received pelvic/abdominal irradiation. The use of irinotecan in patients with significant hepatic dysfunction has not been established. Clinical trials of either dosing schedule, irinotecan was not administered to patients with serum bilirubin >2.0 mg/dL, or transaminase >3 times the upper limit of normal if no liver metastasis or transaminase >5 times the upper limit of normal with liver metastasis. However in clinical trials of the weekly schedule, it has been noted that patients with modestly elevated baseline serum total bilirubin levels (1.0 to 2.0 mg/dL) have had a significantly greater likelihood of experiencing first-course grade 3 or 4 neutropenia than those with bilirubin levels that were less than 1.0 mg/dL {50.0%[19/38]17.7%[47/226]; <0.001}. Patients with abnormal glucuronidation of bilirubin, such as those with Gilbert's Syndrome, may also be at greater risk of myelosuppression when receiving therapy with irinotecan. An association between baseline bilirubin elevations and an increased risk of late diarrhea has not been observed in studies of the weekly dosage schedule.
Laboratory Tests: Careful monitoring of white blood cell count with differential, haemoglobin, and platelet count is recommended before each dose of irinotecan.
Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term carcinogenicity studies with irinotecan were not conducted. Rats were, however, administered intravenous doses of 2 mg/kg or 25 mg/kg irinotecan once per week for 13 weeks (in separate studies the 25 mg/kg dose produced an irinotecan Cmax and AUC that were about 7.0 times and 1.3 times the respective values in patients administered 125 mg/m2 weekly) and were then allowed to recover for 90 weeks. Under these conditions, there was a significant linear trend with dose for the incidence of combined uterine horn endometrial stromal polyps and endometrial stromal sarcomas. However, atrophy of male reproductive organs was observed after multiple daily irinotecan doses both in rodents at 20 mg/kg (which in separate studies produced an irinotecan Cmax and AUC about 5 and 1 times, respectively, the corresponding values in patients administered 125 mg/m2 weekly) and dog at 0.4 mg/kg (which in separate studies produced an irinotecan Cmax and AUC about one-half and 1/15, respectively, the corresponding values in patients administered 125 mg/m2 weekly).
Use in Children: The use and effectiveness of irinotecan in pediatric patients have not been established.
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